According to the reporter, during operative hysteroscopy, removal of possible fibroid, the scope was already in the uterus.The value of the fluid bags: 25g.Value of canisters: -181g.Should read 0 and at a minimum be <100g.The machine registered a deficit of 4300ml, but a manual count showed it to be between 600-800ml.Fluid deficit would spike when canisters were changed.Even just pulling the tubing off the canister before actually removing would increase the deficit 35ml and would never correct itself.They manually count of the fluid deficit to complete the procedure.After the procedure they did a scale test but it failed.There was no patient injury.
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Correction: d3( mfr name, street1, mfr city, mfr region, country code, postal code), g1, g3, h6 this event has been reassessed and found not to be a reportable event.It was concluded that the device was not manufactured by medtronic and medtronic is not responsible for reporting events for this device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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